MHRA Consultantion: End of Sell through unlicensed herbal Products

The MHRA is currently holding a public consultation to end the ‘grace’ period on the sell through of unlicensed herbal products by 31 Dec 2013. The Traditional Herbal Medicinal Products Directive (THMPD) 2004 set out requirements to license such products by demonstrating safety and traditional use (30 years, 15 of which in EU for same or similar formula and indication). The THMPD came into full force in the UK in April 2011, but the MHRA considered the adverse impact on business and created a grace period for selling unsold stocks. They now consider these products have probably gone off or been sold by now. Traditional use data from the early 80s has proven very hard to come by, particularly for non-European companies, and the expense of Good Manufacturing Practice compliance has put others off. In the meantime the MHRA has processed over 300 traditional herbal registrations (THRs) under the THMPD. The vast majority of these products are mono ingredient products. The debate over the value of the THMPD legislation continues…Response to the consultation is invited until the 06 Sep 2013. Click on link http://www.mhra.gov.uk/Publications/Consultations/Generalconsultations/CON296405